If you like to work in a dynamic company, facing new challenges and opportunities every day, then PharmaLex a.r.c. gives you the chance to launch and develop your career.
PharmaLex Group combines local expertise with global reach in the area of Development Consulting, Regulatory Affairs, Pharmacovigilance, Epidemiology & Risk Management and Quality Management & Compliance. We have extensive experience in all major therapeutic areas and product groups including advanced therapy medicinal products, biopharmaceuticals, medicinal & borderline products as well as alternative therapeutic approaches.
PharmaLex has a presence in more than 17 countries with a team of 750+ professionals. We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance. A team of unique people with different skills and strengths stands at the heart of our success. Become part of this diverse team and benefit from flat hierarchies in a collegial working atmosphere.
► We foster commitment – while giving room for flexibility
► We promote and demand – while allowing a work-life-balance
► We motivate people – we think ahead
► We bring people together – while focusing on connectedness
We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment and continually develop our company. So, if your career is not only your job, but also your passion, and you enjoy working and communicating with people, come and join us! The right people are critical to our business success.
Senior Regulatory Affairs Specialist (PreClinical & Clinical)
- Prepare or contribute to the writing/review/preparation of the clinical part of regulatory dossiers and documents
- MAA request in France and Europe as well as renewals and variations for new products, new pharmaceutical form/pathway/indication, generics, OTC, herbal medicine…
- Request for exemption
- Open Access Dossier
- Audit dossiers (before submission to authorities, transfers, etc…
- Assess the clinical content of the dossiers (France and EU)
- Support our clients in the preparation of agency meetings
- e-CTD formatting (all type of procedures)
- Follow up on dossiers for EU procedures
- Ensure compliance with the quality procedures and standards
- Completed University degree in Pharmacy or Medicine.
- A minimum of 5 years of professional experience and, technical/project management experience in the pharmaceutical industry or a consulting environment
- Familiar with French and European regulatory requirements for medicinal products
- Native French speaker and fluency in spoken and written English
- Distinctly strong service orientation
- Ability to cope with short deadlines
- Experience in bibliographic search and analysis
- Content-related experience in at least one relevant area of Regulatory Affairs
- Advanced Word and Acrobat Pro knowledge
- Ability to manage several projects with limited guidance
- Independent approach to work, flexibility and dedication
- Strong communication skills, social competency, integration capacity
- Strong sense of responsibility, organizational skills and intrinsic motivation
If you are interested to take over this most challenging job opportunity in our future-oriented company and want to develop as well as our company, we look forward to receiving your application documents stating your earliest possible starting date and salary expectations online.
Ms. Laura Escabias
Senior European Recruitment Specialist
Contact phone: 0034 912 16 39 49